Sr Director, Pharmacometrics Group Lead

CSL

Americas, US-PA, King of Prussia, CSL Behring +1 more Onsite Research Development & Sciences

About this role

Responsibilities:

• Head an integrated Clinical Pharmacology (and may have Early Development) capability in support of R&D programs. This includes consideration of staff, systems and processes that provide best practice approaches to clinical development initiatives

• Oversee and develop innovative globally applicable clinical pharmacology strategy in support of investigational products entering early development and those moving through later development. This requires a broad appreciation of all CSL therapeutic areas of interest

• Ensure the use of innovative analytical methods such as pharmacometrics/modeling and simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs throughout the clinical development program as well as during life cycle management

• Ensure principles of ethnopharmacology are applied to global R&D programs to ensure optimal development of these programs

• Provide support to Research and CTS and in the development of preclinical PK-PD knowledge required for development of the Entry-into-Human strategy

• Provide senior clinical pharmacology, pharmacometric and early clinical development representation at internal R&D review meetings (PRC and pre- Pharma Plan as required) and represent CSL at regulatory agency interactions

Qualifications:

• PhD/PharmD with a clinical pharmacology research fellowship. Ideally, board specialized in clinical pharmacology or extensive experience in another clinical pharmacology discipline, e.g. pharmacokinetics

• 12+ years of pharmaceutical industry (or relevant) experience, specifically contributing to the clinical pharmacology aspects of clinical drug development

• Thorough understanding of general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK/PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development

• 10+ years in leadership role

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.